NCT04345822

Brief Summary

Myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. Anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. We aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

March 31, 2020

Last Update Submit

April 12, 2020

Conditions

Keywords

heart rate variabilitycervical myelopathyblood pressuredecompression

Outcome Measures

Primary Outcomes (3)

  • change of blood pressure

    noninvasive blood pressure

    one day before surgery, during surgery, 3 months after surgery, 6 months after surgery

  • change of hear rate variability

    from analysis of ECG

    one day before surgery, during surgery, 3 months after surgery, 6 months after surgery

  • baroreflex activity

    from analysis of arterial blood pressure waveform

    during surgery (anesthesia)

Secondary Outcomes (2)

  • change of Japanese Orthopaedic Association Scores

    one day before surgery, 3 months after surgery, 6 months after surgery

  • change of the Nurick scores

    one day before surgery, 3 months after surgery, 6 months after surgery

Study Arms (2)

normotension

patients without diagnosis or treatment for hypertension

Procedure: Decompression surgery

hypertension

patients with diagnosis or treatment for hypertension

Procedure: Decompression surgery

Interventions

The surgeries aim to relieve the myelopathy from cord compression

Also known as: cervical spine decompression surgery
hypertensionnormotension

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We exclude patients with other cormobidity that might lead to hypertension or hypetension. we perfrom age and gender matched pair.

You may qualify if:

  • cervical spine surgery for cord compression

You may not qualify if:

  • spinal cord injury
  • ASA class \>3
  • chronic kidney disease
  • congestive heart failure
  • BMI\>30
  • atrial fibrillation/ flutter
  • obstructive sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei County, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • MC HO, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    STUDY CHAIR

Central Study Contacts

Ya-Chun Chu, MD, PhD

CONTACT

Wen-Cheng HUANG, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 14, 2020

Study Start

February 1, 2020

Primary Completion

March 31, 2021

Study Completion

August 31, 2021

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations